FDA-Device2019-05-01Class II
VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents, and VITROS Immunodiagnostic Products Reagents
Ortho-Clinical Diagnostics
Hazard
One of the software algorithms used to detect sample dispense errors was inadvertently disabled. Because of this, sample dispense errors may lead to incorrect results being reported without an error code to alert the user.
Sold states
Worldwide Distribution - US Nationwide in the states of: AZ, CA, FL, IL, OH, TX, and VA. The products were distributed to the following foreign countries: Australia, Belgium, Canada, Chile, Columbia, France, India, Italy, Japan, Portugal, Singapore, Spain, United Kingdom
Affected count
80
Manufactured in
100 Indigo Creek Dr, N/A, Rochester, NY, United States
Products
VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents, and VITROS Immunodiagnostic Products Reagents
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1222-2019Don't want to check this manually?
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